A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03441555|
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML)||Drug: Venetoclax Drug: Alvocidib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||May 30, 2018|
|Estimated Primary Completion Date :||November 8, 2019|
|Estimated Study Completion Date :||April 21, 2021|
Experimental: Venetoclax + Alvocidib
Venetoclax administered orally once daily (QD) and Alvocidib administered as an intravenous infusion on Days 1, 2, and 3 for all 28-day treatment cycles. Different combinations of dose levels for venetoclax and alvocidib may be explored.
Other Name: ABT-199
Other Name: Flavopiridol
- Tmax of venetoclax [ Time Frame: Approximately 32 days after first dose of study drug ]Time to maximum plasma concentration (Tmax) of venetoclax
- Clearance of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Clearance (CL) of alvocidib
- AUC0-∞ of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of alvocidib
- Cmax of Venetoclax [ Time Frame: Approximately 32 days after first dose of study drug ]Maximum plasma concentration (Cmax) of venetoclax
- Half-life (t1/2) of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Half-life (t1/2) of alvocidib
- AUC0-24 Post-dose of Venetoclax [ Time Frame: Approximately 32 days after first dose of study drug ]Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
- Cmax of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Maximum plasma concentration (Cmax) of alvocidib.
- AUCt Post-dose of Alvocidib [ Time Frame: Approximately 32 days after first dose of study drug ]Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose alvocidib.
- Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for Venetoclax and Alvocidib [ Time Frame: Minimum first cycle of dosing (up to 28 days) ]RPTD will be determined using available safety and pharmacokinetics data upon completion of the dose escalation phase.
- Complete Response (CR) Rate [ Time Frame: Up to approximately 8 months ]CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.
- Combined CR Rate [ Time Frame: Up to approximately 8 months ]Combined CR rate is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 18 months ]ORR is defined as the proportion of participants with documented partial response (PR) or better based on IWG criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441555
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|United States, California|
|USC Norris Cancer Center /ID# 170844||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|UC Irvine /ID# 201093||Recruiting|
|Orange, California, United States, 92868|
|UC Davis Comp Cancer Ctr /ID# 170799||Recruiting|
|Sacramento, California, United States, 95817|
|United States, Florida|
|Sylvester Comprehensive Cancer /ID# 170761||Recruiting|
|Miami, Florida, United States, 33136-1002|
|United States, Indiana|
|Indiana Blood & Marrow Transpl /ID# 170793||Recruiting|
|Indianapolis, Indiana, United States, 46237|
|United States, New York|
|NYU Langone Medical Center /ID# 201559||Recruiting|
|New York, New York, United States, 10016-6402|
|Weill Cornell Medical College /ID# 170800||Not yet recruiting|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Duke Univ Med Ctr /ID# 170842||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|University of Pittsburgh Medic /ID# 170790||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Universitaetsklinikum Ulm /ID# 203649||Not yet recruiting|
|Ulm, Thueringen, Germany, 89081|
|Universitaetklinikum Dresden /ID# 168636||Not yet recruiting|
|Dresden, Germany, 01307|
|Univ Klinik Eppendorf Hamburg /ID# 168633||Not yet recruiting|
|Hamburg, Germany, 20246|
|University Hospital of Wales /ID# 202302||Not yet recruiting|
|Cardiff, United Kingdom, CF14 4EN|
|Ninewells Hospital /ID# 202304||Recruiting|
|Dundee, United Kingdom, DD1 9SY|
|St. James University Hospital /ID# 202303||Not yet recruiting|
|Leeds, United Kingdom, LS9 7TF|
|Study Director:||AbbVie Inc.||AbbVie|